QC Specialist IV - Raw Materials

Lonza•Portsmouth, NH

About The Position

Location: The actual location of this job is in Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. This role is a key contributor to the raw material release process, coordinating the flow of materials from receipt through testing, data authorization, and final release. It offers the opportunity to lead cross-functional and external projects while ensuring compliance with global compendial and cGMP requirements. What you will get: ● An agile career and dynamic working culture ● An inclusive and ethical workplace ● Compensation programs that recognize high performance ● Medical, dental and vision insurance Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits. At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. Ready to shape the future of life sciences? Apply now.

Requirements

Experience supporting raw material testing, release, or quality activities in a cGMP-regulated environment
Working knowledge of pharmacopeial requirements (USP, EP, JP) and their application to raw material testing and documentation
Advanced proficiency in Microsoft Office applications, particularly Word and Excel
Experience with document management systems (DMS), document control, and change management practices
Strong technical writing, proofreading, and editing skills for protocols, reports, specifications, and methods
Familiarity with computerized management systems such as LIMS and SAP
Ability to interpret written and verbal instructions clearly, manage timelines, and lead projects across stakeholders

Responsibilities

Coordinate the end-to-end raw material release process, including receipt, sampling, testing, data authorization, and archival
Support raw material sampling, testing decisions, sample distribution, and data management within LIMS, including template creation and review-driven corrections
Prepare and maintain raw material documentation packets from receipt through release and long-term archival
Function as project manager for externally tested raw materials, coordinating internal stakeholders and external laboratories through routine touchpoints
Generate and manage blanket purchase orders for external testing, including invoice reconciliation in SAP
Own and/or manage SOPs and work instructions related to raw material coordination activities
Participate in and lead strategic projects to improve the health, efficiency, and robustness of raw material testing, including data trending and historical analysis